Myelodysplastic Syndrome Clinical Trial
Study of Vadastuximab Talirine (SGN-CD33A; 33A) in Combination With Azacitidine in Patients With Previously Untreated Higher Risk MDS
Summary
This is a phase 1/2 study to evaluate the combination of vadastuximab talirine (SGN-CD33A; 33A) and azacitidine in subjects with previously untreated International Prognostic Scoring System (IPSS) Intermediate-2 or high risk myelodysplastic syndrome (MDS).
Full Description
In the phase 1 portion of the study, escalating doses of 33A will be evaluated in combination with azacitidine, and a dose of 33A will be selected to proceed to phase 2. The phase 2 portion of the study is randomized, double-blind and placebo-controlled; it is designed to compare the overall response rate (ORR) between 2 study arms.
Eligibility Criteria
Inclusion Criteria:
Subjects with cytologically/histologically confirmed MDS according to the World Health Organization (WHO) 2008 classification.
Previously untreated for Myelodysplastic Syndrome (MDS)
Age ≥18 years of age.
Eligible for therapy with azacitidine.
Life expectancy of at least 12 weeks.
Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
Adequate baseline laboratory parameters.
Exclusion Criteria:
Received prior treatment for MDS with lenalidomide or hypomethylating agents (HMAs).
History of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis.
Second malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment, eg, prostate or breast cancer).
Candidates for allogeneic stem cell transplant at the time of screening.
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There are 8 Locations for this study
Gilbert Arizona, , United States
Los Angeles California, 90033, United States
Aurora Colorado, , United States
Denver Colorado, , United States
Denver Colorado, , United States
Fleming Island Florida, , United States
Jacksonville Florida, 32224, United States
Augusta Georgia, , United States
Chicago Illinois, , United States
Bethesda Maryland, , United States
Ann Arbor Michigan, , United States
Detroit Michigan, , United States
Minneapolis Minnesota, , United States
Bozeman Montana, , United States
Hackensack New Jersey, , United States
Albuquerque New Mexico, , United States
Brooklyn New York, , United States
Hawthorne New York, 10532, United States
New York New York, , United States
Chapel Hill North Carolina, 27514, United States
Winston-Salem North Carolina, 27157, United States
Cleveland Ohio, , United States
Columbus Ohio, 43210, United States
Portland Oregon, 97213, United States
Portland Oregon, 97239, United States
Philadelphia Pennsylvania, , United States
Charleston South Carolina, , United States
Nashville Tennessee, , United States
Austin Texas, , United States
Dallas Texas, , United States
Houston Texas, , United States
San Antonio Texas, , United States
Seattle Washington, , United States
Milwaukee Wisconsin, , United States
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